India bites back on drug recall

The Indian government halted wide-ranging trade talks with the European Union in retaliation for the withdrawal of the bloc’s authorization for some 700 medicines made in India.

India said it had “taken a decision to defer the proposed talks between the chief negotiators on the India–EU Broadbased Investment and Trade Agreement for the present.”

The negotiations have been underway since 2007, and cover market access for goods and services, public procurement, investment, intellectual property and competition, as well as sustainable development.

However, the European Commission recently formalized a recommendation from the European Medicines Agency to suspend medicines based on clinical studies conducted at GVK Biosciences. The decision has EU-wide effect, and the medicines are now being withdrawn from pharmacy shelves.

The recommendation was made on safety grounds, and arose from concerns from the French medicines agency, which found systematic data manipulations of electrocardiograms during a site inspection.

The EMA said the findings of the inspectors “cast doubt on the integrity of the conduct of trials at the site generally and on the reliability of data generated.”

The Indian government statement says the pharmaceutical industry “is one of the flagship sectors of India which has developed its reputation through strong research and safety protocols over the years.”

It is particularly disappointed that the EU decision has been taken despite the fact that “the government has engaged on the issue with various EU regulators over past eight months,” adds the statement.